Quala Dental Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect
Quala Dental Products topical anesthetic gel (20% benzocaine) is recalled due to manufacturing equipment defects. The bulk product was inadvertently released despite Quality Unit rejection after inspection found scratches on the mixing vessel.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving manufacturing defects (scratches on the mixing vessel) that create a contamination risk in a product applied to oral tissues. Although no illnesses or injuries have been reported, the defect poses a risk of harm to users and meets the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Quala Dental Products Topical Anesthetic Gel containing 20% benzocaine (Lot No. BNZ-001646, expiration date 11/26/2026) is being recalled.
The U.S. Food and Drug Administration issued this Class II recall due to manufacturing (CGMP) deviations. During routine inspection of the production mixing vessel, scratches were discovered on the sides and bottom. Although the Quality Unit rejected the bulk product upon discovery of these defects, the product was inadvertently released and shipped to customers.
The recalled product was distributed nationwide in the United States and Canada, as well as to the Dominican Republic, El Salvador, Honduras, and Qatar. The product manufacturer is Keystone Industries, made for NDC, Inc., located at 407 New Sanford Road, La Vergne, TN 37086.
The recalled product
- Product
- Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com
- Manufacturer
- Keystone Industries
- Category
- Drug — Topical Anesthetic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot No.: BNZ-001646
- Exp Date: 11/26/2026
- Keystone Item No. 03-64419
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Keystone Industries under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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